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IRCT20180124038488N2 IRCT 2021-06-18 Zanjan University of Medical Sciences Comparison of morphine with midazolam-morphine combination in reducing pain Comparison of the effect of morphine alone with midazolam-morphine combination in reducing pain on Burnt Patients 2019-01-05 anticipated 100 Complete https://irct.ir/trial/36502 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization will be used to assign individuals to intervention and control groups, because the outcome is evaluated in different time periods and with this method, the number of samples assigned to each of the study groups in different time periods will be equal. To create a random sequence, online randomization will be used, for which the website https://www.sealedenvelope.com is designed to generate a block randomization sequence. Then block size will be 4 and finally 25 blocks will be created and 50 people will be divided into two groups, Blinding description: Patients in this study will not know the type of intervention received because both types of drug intervention in the two groups will be performed by injection. Also, assessment of pain intensity (Visual analogue scale) as the main outcome (primary outcome) in both groups It will be done by an observer outside the research team, which is blind to the type of intervention and the allocation of individuals to intervention and control groups. Therefore, it can be said that this study is a double blind study and patients and observer will be unaware of the type of intervention and the allocation of individuals to intervention and control groups. 3 Condition 1: thermal burn. Condition 2: thermal burn. Condition 3: thermal burn. Condition 4: thermal burn. Condition 5: thermal burn. Condition 6: thermal burn. Intervention 1: Intervention group: In group one or intervention, patients were treated with two syringes containing clear liquid prepared in advance by the study supervisor. The number one syringe contains 10 ml of midazolam (made by Elixir Company) with a concentration of half a milligram per milliliter and is injected intravenously at a dose of 0.08 milliliters per kilogram of body weight for one minute. In the second syringe, 10 ml of intravenous morphine sulfate solution made by Iranian pharmaceutical factories (Darupakhsh) with a concentration of one mg per ml, which is injected at a dose of 0.1 milliliter per kilogram of body weight. Intravenous midazolam is injected only once. Intervention 2: Control group: In group two or control group, patients were treated with two syringes containing 10 ml of clear liquid that had been prepared by the study supervisor. In syringe number one, there was ten milliliters of distilled water as a placebo, which is injected intravenously at a dose of 0.08 milliliters per kilogram of body weight, and in syringe number two, ten milliliters of intravenous morphine sulfate solution made by Iranian pharmaceutical factories ( Darupakhsh) with a concentration of one milligram per milliliter, which is injected at a dose of 0.1 milliliter per kilogram of body weight. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people When: May 2020 To whom: Only for researchers working in medical universities Conditions: No specific conditions Where to obtain: Dr Mohsen Salehi, Assistant Professor of Emergency Medicine Department, Zanjan University of Medical Sciences, m.salehi@zums.ac.ir How to obtain: Sending an e-mail containing a formal application, along with providing job approvals Comments:
public Dr Mohsen Salehi
Valiasr Hospital, Valiasr Square
Zanjan Iran (Islamic Republic of) 45157-77978 +98 24 3377 0801 M.salehi@zums.ac.ir Zanjan University of Medical Sciences scientific Dr Mohsen Salehi
Valiasr hospital, Valiasr square
Zanjan Iran (Islamic Republic of) 45157-77978 +98 24 3377 0801 M.salehi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Complete awareness and GCS 15/15 Patient between the ages of 18 and 65 years having physical and mental ability to answer questions non-inhaled burn stable hemodinamic status lack of addiction 18 years 65 years Both pregnancy Allergy to opioids patients with psychological problems people with known cardiac, renal and hepatic diseases. T20 T21 T22 T23 T24 T25 Burn and corrosion of head, face, and neck Burn and corrosion of trunk Burn and corrosion of shoulder and upper limb, except wrist and hand Burn and corrosion of wrist and hand Burn and corrosion of lower limb, except ankle and foot Burn and corrosion of ankle and foot Treatment - Drugs Treatment - Drugs Intervention group: In group one or intervention, patients were treated with two syringes containing clear liquid prepared in advance by the study supervisor. The number one syringe contains 10 ml of midazolam (made by Elixir Company) with a concentration of half a milligram per milliliter and is injected intravenously at a dose of 0.08 milliliters per kilogram of body weight for one minute. In the second syringe, 10 ml of intravenous morphine sulfate solution made by Iranian pharmaceutical factories (Darupakhsh) with a concentration of one mg per ml, which is injected at a dose of 0.1 milliliter per kilogram of body weight. Intravenous midazolam is injected only once. Control group: In group two or control group, patients were treated with two syringes containing 10 ml of clear liquid that had been prepared by the study supervisor. In syringe number one, there was ten milliliters of distilled water as a placebo, which is injected intravenously at a dose of 0.08 milliliters per kilogram of body weight, and in syringe number two, ten milliliters of intravenous morphine sulfate solution made by Iranian pharmaceutical factories ( Darupakhsh) with a concentration of one milligram per milliliter, which is injected at a dose of 0.1 milliliter per kilogram of body weight Pain relief. Timepoint: At the beginning of the patient's entry into the burn room and at the beginning of the dressing and at times zero, 20, 60 and 120. Method of measurement: Visual analogue scale. Zanjan University of Medical Sciences Approved 2018-12-18 Ethics committee of Zanjan University of Medical Sciences Vice Chancellor for Research and Technology,Third Floor, Headquarters of Zanjan University of Medical Sciences, Second Building, Azadi Blvd. Zanjan Zanjan Iran (Islamic Republic of)